Overweight and Obesity
Conditions
Keywords
nutrition, diet, genetics, physical activity, weight loss
Brief summary
Excess weight is a major risk factor underlying leading causes of death globally, including cardiovascular disease, type 2 diabetes, and some cancers. Among participants assigned to the same lifestyle intervention arms in prior weight loss randomized controlled trials, large inter-individual differences in weight loss success have been observed, ranging from \>50lbs of weight loss to \>10lbs of weight gain. Both genetic and non-genetic factors underlying differential adherence and weight loss success are poorly understood.
Detailed description
23andMe aims to recruit 91,227 adults to participate in a web-based weight loss intervention. Primary aims include: a.) to confirm whether AG/GG individuals at MTIF3 rs1885988 lose more weight on lifestyle interventions; and b.) to test the performance of a randomized controlled trial vs. self-selection study design in terms of weight loss, drop-outs, and adherence. Secondary (exploratory) analyses will focus on discovery of genetic and non-genetic predictors of weight loss success overall, and examination of potential interactions by intervention type. Web-administered intervention content, videos, and forums will be surfaced to participants every two weeks, and self-reported surveys will be surfaced weekly for the active intervention duration.
Interventions
BEHAVIORALLower carbohydrate diet
Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity
BEHAVIORALHigher fiber diet
Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity
BEHAVIORALPhysical activity focused
Focused on aerobic and resistance exercise, while following dietary guidelines \<https://www.choosemyplate.gov\>
Sponsors
23andMe, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Participants are randomized to either a RCT or 'Participant choice' block, with 3 parallel interventions within each block
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* US-based men and women in self-reported 'good' or better health * Consented to participate in research * BMI 25-40 kg/m2 * Not actively on a weight loss plan * Willing and able to modify eating and physical activity patterns * Not under a doctor's care for a serious medical condition
Exclusion criteria
* Are pregnant, lactating, within 6 months postpartum, or planning to become pregnant in the next 6 months * Have diabetes (type 1 or 2) or are on hypoglycemic medications * Had a heart attack or stroke within the past year * Are unable or unwilling to follow a physical activity or diet intervention due to a medical condition or doctor's orders * Have an eating disorder * Have severe depression, anxiety, or other psychiatric conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight from week 1 to week 12 of intervention | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in waist circumference from week 1 to week 12 of intervention | 12 weeks |
| Change in waist-to-hip ratio from week 1 to week 12 of intervention | 12 weeks |
Countries
United States
Outcome results
None listed